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Clinical Trials (PDQ®)

UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive careCompleted18 and overNCI, OtherCDR0000310163
P30CA046592, CCUM-0201, NCT00064272

Trial Description

Summary

RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

Further Study Information

OBJECTIVES:

Primary

  • Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.

Secondary

  • Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
  • Compare the safety of these regimens in these patients.
  • Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

  • Arm I: Patients receive lower-dose oral ginger twice daily.
  • Arm II: Patients receive higher-dose oral ginger twice daily.
  • Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of cancer
  • Currently receiving chemotherapy* containing any chemotherapeutic agent at any dose and experiencing nausea and/or vomiting of any severity (delayed or acute)
  • Chemotherapy regimens may be given orally, IV, or by continuous infusion (single day regimens only)
  • Must have received at least 1 prior chemotherapy* course containing any chemotherapeutic agent and meets the following criteria:
  • Agent is the same that is scheduled for the next round of chemotherapy
  • Experienced nausea and/or vomiting of any severity (delayed or acute)
  • Must be planning to receive a concurrent 5-HT_3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, dolasetron mesylate, or palanosetron) or antiemetic aprepritant (e.g., Emend®) while on chemotherapy
  • No symptomatic brain metastases NOTE: *Chemotherapy may be adjuvant, neoadjuvant, curative, or palliative

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • No history of bleeding disorder
  • No thrombocytopenia

Hepatic

  • Not specified

Renal

  • Not specified

Gastrointestinal

  • Able to swallow capsules
  • No gastric ulcer
  • No clinical evidence of current or impending bowel obstruction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to understand English
  • Able to complete study questionnaires
  • No allergy to ginger

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No prior chemotherapy regimens with multiple day doses

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy that is classified as high or intermediate risk of causing vomiting, including radiotherapy to any of the following areas:
  • Total body irradiation
  • Hemi-body
  • Upper abdomen
  • Abdominal-pelvic mantle
  • Cranium (radiosurgery)
  • Craniospinal radiotherapy

Surgery

  • Not specified

Other

  • More than 1 week since prior ginger (teas, capsules, tinctures)
  • No other concurrent ginger (teas, capsules, tinctures)
  • Concurrent foods made with small amounts (no more than ¼ teaspoon) of ginger (powdered or fresh) allowed
  • No concurrent therapeutic-doses of warfarin, aspirin, or heparin
  • Concurrent low-dose warfarin to maintain peripheral or central venous access, low-dose aspirin (≤ 81 mg), or low-dose heparin allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

University of Michigan Comprehensive Cancer Center

National Cancer Institute

National Center for Complementary and Alternative Medicine

Suzanna ZickStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00064272
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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